Title Specialist, Regulatory Affairs

Company: MicroVention, Inc.,

Position: Specialist, Regulatory Affairs

Location: Aliso Viejo, CA

Posted: October 2, 2020

This position is responsible for assisting in obtaining regulatory approvals and ensures compliance to International regulatory agency requirements including ISO, local, state and/or federal requirements. This team is responsible for the global registrations of over 30 products into more than 100 countries.  Strong organizational skills and ability to multi-task is a critical requirement.

  1. Serves on product development and operations teams to ensure regulatory compliance.
  2. Executes the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
  3. Writes various technical sections of the regulatory submission.
  4. Prepares regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  5. Integrates various sources of information into a uniform style and language for regulatory submissions.
  6. Documents, consolidates and maintains verbal and written communication with regulatory agencies.
  7. Maintains regulatory files and records.
  8. Reviews change order documents and ascertains impact on current regulatory approvals.
  9. Reviews promotional material and labeling for regulatory compliance as assigned.
  10. Maintains regulatory files and records.
  11. Technical publishing of submissions.
  12. Edits/revises Standard Operating Procedures.
  13. Builds team cohesiveness by influencing and supporting team members.
  14. Performs other duties and responsibilities as assigned.